1. Field of the Invention
This invention relates generally to the analysis of clinical trial budgets. More particularly, this invention relates to a computer-implemented method for analyzing budgets for clinical trials.
2. Background
The life sciences industry includes pharmaceutical and biotechnology companies that are required to perform various phases of clinical trials (also referred to as clinical studies) on new drugs, compounds and medical devices before they can obtain marketing approval from the U.S. Food and Drug Administration or a foreign counterpart. Clinical trials are expensive to conduct and require effective budgeting processes in order to keep costs under control and obtain the best return on investment. The budgeting process for conducting a clinical trial is complex since is often requires the pharmaceutical or biotechnology company, known as the “sponsor” of the trial, to use many different vendor suppliers in addition to its own resources. The process used to select between potential vendor suppliers can profoundly affect a sponsor's clinical trial budget since vendor suppliers can price the same services in significantly different ways and amounts, and the budgeting processes currently used by sponsors cannot identify these pricing differences without significant time and expense as is described below in greater detail.
FIG. 1 illustrates the following example of the flow of budget information into a biotechnology company, which is not intended to be limiting in any way. Several different lists of activities and associated costs (LOAACS) shown on FIG. 1 contain many itemized activities and costs that are proposed in order to complete a clinical trial under a set of specification assumptions. According to an embodiment of the invention, this set of specification assumptions include number of sites, number of patients, number of countries, and the like, that are estimated to be necessary to complete a specific clinical trial. A vendor supplier (a Contract Research Organization or CRO for this example) or an in-house team is given a set of assumption specifications with a list of requested activities by the biotechnology company in the form of a document called a “Request for Proposal” (RFP). The RFP sets forth the specification assumptions and the list of requested activities from which a responder must prepare a budget containing the costs for the activities under the specification assumptions. CROs respond to an RFP in their own standard format and send a number of standard and non-standard documents to the biotechnology company, which is then responsible for analysis of the budget information to properly cost and then perform a clinical trial.
A “budget” as described herein, may be an internal project budget or a bid for outsourced work.
Although the biotechnology company carefully designs the RFP and the CROs or in-house teams might carefully prepare the RFP responses, it is very difficult and time consuming to analyze the budgets provided. This happens because of many different reasons: many activities are necessary to conduct a trial including teleconferences, training, meeting time, and the like; there is no standard terminology; there are no standard categorizations for these activities. For example, one person preparing a budget might use the term “teleconference” for a training session because that is the way the training is conducted, while another person reserves the term “teleconference” for weekly meetings conducted on the telephone. To further add to the confusion, the categories for these activities are not standardized. For example, one person analyzing a budget might classify the “teleconference-training” activity under the category “initial study set up,” while another person will categorize the same activity under the category of “monitoring” because the training is being done for the monitors who will monitor the trial. As there are hundreds of activities and multiple categories, confusion and misunderstandings can quickly multiply.
Similar budget process problems can and do occur within a pharmaceutical company or other companies in the life sciences industry. While this example shows the flow of information in the industry to obtain budget proposals from vendor suppliers such as Contract Research Organizations (CROs), a similar process is used to formulate budgets for other types of vendor suppliers and for in-house resources. Again, a similar process is used if a combination of in-house and vendor resources are used.
In order to try to reduce the confusion, some biotechnology and pharmaceutical companies write detailed RFPs, which provide standard categories and standard terms for activities. Persons who prepare budgets are asked to provide detailed information for the budget within the RFP. A goal of this is to make the analysis process simpler, so that the budgets can be compared, contrasted, and costs understood easily if there is a change in any of the assumption specifications. However, completing and comparing budgets within an RFP has not solved the problem. The reasons that confusion and errors still exist are due to many factors including the following factors:                1. No benchmark libraries of standard terms, costs, categories, activities are easily available.        2. There are few staff that have the detailed financial and operational expertise to do a proper analysis.        3. There are little or no performance metrics linked to cost metrics.        4. Teams and supplier vendors may unintentionally or purposefully leave gaps in the lists of activities needed to complete a clinical trial.        5. Supplier vendors are unable to conform their internal costing, pricing and budgeting to the many different RFPs that their clients expect them to complete.        
Unfortunately, the result of the confusion surrounding the analysis of budgets is that the biotechnology companies and others managing the budgets cannot, for example, make accurate pricing comparisons or compile accurate budgets. These mistakes cause a biotechnology company to pay more than is necessary for some activities. Another problem is that budget overruns are high due to gaps in activities that have not been budgeted. In addition, with the lack of proper budget analysis, the clinical trial often suffers from poor performance, delays and failure.